Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX (CRO-11-108)

Cosmo Technologies

Status and phase: Completed; Phase 2

Conditions: Colon Staining in Preparation for Colonoscopy

Treatments: Drug: Methylene Blue MMX 25 mg modified release tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT03287219

CB-17-01/03

Details and patient eligibility

About

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Full description

Objectives:

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Primary end-point(s):

To evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg.

Secondary end-point(s):

Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS) after intake of 150 or 200 mg of Methylene Blue MMX® tablets during the intake of the bowel cleansing preparation.

To collect data about safety and tolerability of Methylene Blue MMX® tablets after administration of single oral doses of 150 or 200 mg.

Methodology:

Open label, staining efficacy exploratory study.

Enrollment: 114 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Sex: males and females;
2. Age:18 to 70 years;
3. Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
4. Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
5. Informed Consent: signed written informed consent prior to inclusion in the study.

Exclusion criteria

1. Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
2. Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
3. Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, inflammatory bowel diseases in active phase, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other relevant disease that might interfere with the aim of the study.
4. Comprehension: inability to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator and to comply with the requirements of the entire study.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

150 mg Methylene Blue-MMX tablets

Active Comparator group

Description:

take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg

Treatment:

Drug: Methylene Blue MMX 25 mg modified release tablets

200 mg Methylene Blue-MMX tablets

Active Comparator group

Description:

take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg

Treatment:

Drug: Methylene Blue MMX 25 mg modified release tablets